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Manufacturing Expert (gn) (EN)

[5159]
Medical, Pharma-, Medizinprodukte, Produktion

As part of our client's team, you will play a central role in finding solutions to some of the biggest scientific challenges of our time.  Our client's goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel treatments for cancer and infectious diseases. We are looking for a dedicated individual to join us as soon as possible as a Manufacturing Expert (gn) Your tasks ·Leading cross-functional root cause analysis and problem solving on quality issues (e.g., recurring deviations, quality-investigations, Corrective and Preventive Action (CAPA) studies) ·Supporting at site in cross-functional teams (e.g., revalidation, laboratory remediation) with IQP champions, project managers and Quality Assurance managers to implement manufacturing process changes ·Co-leading continuous improvement and cost reduction projects ·Supporting manufacturing and quality teams as technical personnel and managing technical affairs with internal and external stakeholders ·Supporting the creation and maintenance of relevant production documents, e.g. Standard Operating Procedures SOPs, batch instructions, protocols, and validation reports Your qualifications ·University degree in (Life) Science, Engineering or a medical field ·Practical, hands-on experience and very strong expertise in on-site manufacturing and quality assurance within the life science industry ·Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) ·Creativity and the ability to develop a flexible approach to changing conditions in challenging situations with a can-do mentality ·High team spirit, excellent collaborating skills, and effective stakeholder management skills ·Profound knowledge of EU / US GMP guidelines and regulatory standards ·Good process management skills, Lean and Six Sigma qualifications preferred ·Very good communication skills, fluency in German and English You will be offered ·Company Pension Scheme ·Childcare ·Jobticket ·Company Bike ·Leave Account ·Fitness Courses ·Mobile Office ·Special Vacation ... and much more

As part of our client's team, you will play a central role in finding solutions to some of the biggest scientific challenges of our time. 
Our client's goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel treatments for cancer and infectious diseases.

We are looking for a dedicated individual to join us as soon as possible as a


Manufacturing Expert (gn)

Your tasks
  • Leading cross-functional root cause analysis and problem solving on quality issues (e.g., recurring deviations, quality-investigations, Corrective and Preventive Action (CAPA) studies)
  • Supporting at site in cross-functional teams (e.g., revalidation, laboratory remediation) with IQP champions, project managers and Quality Assurance managers to implement manufacturing process changes
  • Co-leading continuous improvement and cost reduction projects
  • Supporting manufacturing and quality teams as technical personnel and managing technical affairs with internal and external stakeholders
  • Supporting the creation and maintenance of relevant production documents, e.g. Standard Operating Procedures SOPs, batch instructions, protocols, and validation reports


Your qualifications

  • University degree in (Life) Science, Engineering or a medical field
  • Practical, hands-on experience and very strong expertise in on-site manufacturing and quality assurance within the life science industry
  • Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs)
  • Creativity and the ability to develop a flexible approach to changing conditions in challenging situations with a can-do mentality
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • Profound knowledge of EU / US GMP guidelines and regulatory standards
  • Good process management skills, Lean and Six Sigma qualifications preferred
  • Very good communication skills, fluency in German and English


You will be offered

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more

map Region Mainz date_range 01.11.2021 update Permanent
Medizinprodukte Pharma- Medical Produktions-


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